On October 22, the Food and Drug Administration (FDA) put Fumizer’s flavored vaping products back under review—rescinding the denial it had issued in September. The reversal marks the second such rescission from the agency to date.
In early September, the FDA issued a marketing denial order (MDO) for Fumizer’s flavored vaping products.
The company, like all others in the United States, had until September 2020 to file a premarket tobacco product application (PMTA) in order for its vapes and e-liquids to remain on the marketplace. The FDA, in turn, had until September 2021 to look over the PMTAs, which companies had to submit for every single product they wanted to keep selling.
The FDA’s rescission by no means ensures that Fumizer’s vapor products will eventually receive authorization. But the move, amid a flurry of lawsuits against the FDA from dozens of vapor companies, might be indicating a pattern: namely that the agency, in its rush to meet a court-imposed deadline, did not consider evidence that would indicate these products met the standard of being “appropriate for the protection of public health.”
Alex Norcia – Filter – 2021-10-25.
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